Status:
COMPLETED
Evaluation of Three Potential Central Nervous System (CNS) Pretreatments for Soman Exposure on Human Performance
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
Walter Reed Army Institute of Research (WRAIR)
Conditions:
Biomarkers, Pharmacological
Eligibility:
All Genders
18-39 years
Brief Summary
The primary objective of this study is to determine whether huperzine A, donepezil, and galantamine impact militarily relevant aspects of neurocognitive performance in humans, compared to placebo.
Detailed Description
The primary objective of this study is to determine whether huperzine A, donepezil, and galantamine impact militarily relevant aspects of neurocognitive performance in humans, compared to placebo. Se...
Eligibility Criteria
Inclusion
- All healthy men and women 18 to 39 years of age are eligible to participate.
Exclusion
- Must be able to swallow whole pills.
- Self-reported habitual nightly sleep amounts outside the target range of 6-8 hours (i.e., less than 6 hours per night or more than 8 hours per night, on average)
- Cardiovascular disease (to include but not limited to arrhythmias, valvular heart disease, congestive heart failure, family history of sudden cardiac death or myocardial infarction) as determined by participant self report.
- Current hypertension or high blood pressure (greater than 140/90)
- Neurologic disorder (to include but not limited to epilepsy or another seizure disorder, amnesia for any reason, hydrocephalus, MS, narcolepsy or other sleep disorders)
- Kidney disease
- History of psychiatric disorder requiring hospitalization or psychiatric medication for any length of time
- Beck Depression Inventory score of 14 or above
- Underlying pulmonary disease requiring daily inhaler use
- Regular nicotine use (or addiction) (defined as more than 1 cigarette or equivalent per week) within the last 3 years
- Heavy alcohol use (more than 2 drinks per day; http://www.cdc.gov/alcohol/faqs.htm#10)
- Use of other illicit drugs (to include but not limited to benzodiazepines, amphetamines, cocaine, marijuana)
- Known liver disease or liver abnormalities as determined by a laboratory test
- Known ulcer disease or risk of ulcer disease (stomach bleeding)
- Self-reported history of caffeine use in excess of 400 mg (8 caffeinated sodas or 3-4 cups, each \~ 6 oz, of coffee) per day on average
- Pregnancy (females)
- Breast-feeding (females)
- Prior anaphylactic reaction, angioedema, or other severe psychological reactions to any of the test compounds
Key Trial Info
Start Date :
February 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT01194336
Start Date
February 1 2012
End Date
October 1 2012
Last Update
May 3 2017
Active Locations (1)
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1
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States, 20910